Investigation of Motorized Lower-limb Prostheses
NCT07584707 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-05-13
Summary
The goal of this clinical trial is to learn if a motorized prosthesis can improve mobility in individuals with amputation. The main question it aims to answer is:
* Does motorized prosthesis improve ambulation speed, balance, control, or efficiency when performing everyday activities?
* What problems arise when using a motorized prosthesis? Researchers will compare mobility of the participants when using and not using the motorized prosthesis to see if mobility and/or function improves.
Participants will perform various activities with and without the motorized prosthesis including:
* Walking at a mild incline/decline (0°-15°) on treadmill or over-ground
* Ascending or descending stairs
* Stand to sit and sit to stand transitions
* All terrain walking over ground
* Turning
* Any combination of the above-mentioned activities
Conditions
- Ambulation With the "Take Home" or Passive Prosthesis
- Ambulation With the Motorized Prosthesis in the "Off" Configuration
- Ambulation With the Motorized Prosthesis in the "Transparent" Condition
- Ambulation With the Motorized Prosthesis in the "Powered" Condition
Interventions
- DEVICE
-
Motorized prosthesis
The motorized prosthesis is an experimental device. The device is constructed from plastic and metal. It has motors, sensors, and electronic systems to control the prosthesis to mimic the behavior of a biological joint. The device is determined non-significant risk by the sponsor's Institutional Review Board.
- DEVICE
-
Passive prosthesis
The participant will perform the study protocol with their "take home" prosthesis and/or another suitable passive prosthesis.
Sponsors & Collaborators
-
Northern Arizona University
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-04-16
- Primary Completion
- 2029-03-15
- Completion
- 2029-03-15
- FDA Device
- Yes
Countries
- United States
Study Locations
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